PMA P940010S003
- Device
- OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S003
- Product code
- MVG
- Decision date
- 1997-04-04
- Classification
- System, Laser, Fiber Optic, Photodynamic Therapy
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Approval order statement
- APPROVAL FOR LABELING CHANGES ASSOCIATED WITH THE INTRODUCTION OF A SECOND DISTRIBUTOR
Current openFDA PMA Record#
- Device
- OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S003
- Product code
- MVG
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Decision date
- 1997-04-04
- Decision code
- APPR
- Date received
- 1997-02-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES ASSOCIATED WITH THE INTRODUCTION OF A SECOND DISTRIBUTOR